This phase II trial studies how well pemetrexed disodium and carboplatin work in treating patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:

Overall objective response rate (RR) based on Response Evaluation Criteria in Solid Tumors and by Rustin Criteria (RECIST) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]

An exact 95% confidence interval for the tumor RR will be calculated based on the binomial distribution.

Secondary Outcome Measures:

Incidence of toxicities assessed according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0. [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]

Each of the grade 3 or 4 hematologic and non-hematologic toxicities will be determined and divided by the total number of patients to calculate the frequency for each toxicity over the study population. The number of adverse events will also be divided by the number of chemotherapy cycles to determine the frequency per treatment course.

Overall survival [ Time Frame: First day of treatment on protocol to the date of death, or for living patients the last date of contact, assessed up to 8 years ] [ Designated as safety issue: No ]

Kaplan-Meier method will be used to analyze the time-to-event data including overall survival.

Progression-free interval [ Time Frame: Time from the first day of treatment to the day that progression is first noted, assessed up to 8 years ] [ Designated as safety issue: No ]

Kaplan-Meier method will be used to analyze the time-to-event data including progression free interval.

Patients receive pemetrexed disodium IV over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive pemetrexed disodium intravenously (IV) over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients must have a histopathologically confirmed diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube carcinoma

Patients must have received at least 1 prior platinum and taxane based chemotherapy regimen; patients may have failed no more than 2 prior chemotherapy regimens

Patients must have "platinum sensitive" disease, which will be defined as those patients with relapsed disease who had an initial complete remission, and relapsed more than 6 months after completion of initial platinum based chemotherapy

Recurrent disease must be confirmed by:

Bidimensionally measurable disease which can be measured by physical examination or by means of medical imaging techniques (measurable disease)

Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 2.0 cm when measured by conventional techniques, including palpation, x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 1.0 cm when measured by spiral CT; all measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and will be recorded and measured at baseline; all baseline evaluations of disease status should be performed as close as possible to the start of treatment and never more than 4 weeks before the beginning of treatment

Target lesions should be selected on the basis of their size (lesions with the longest dimension, LD) and their suitability for accurate repetitive measurements by one consistent method of assessment (either clinically or by imaging techniques); a sum of LD for all target lesions will be calculated and reported as the baseline sum LD; the baseline sum LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease; all other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline OR

Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< three times the upper normal institutional limits; if patient has known hepatic metastases, patients may be enrolled if liver function test is =< five times the upper normal institutional limits

Alkaline phosphatase =< three times the upper normal institutional limits; if patient has known hepatic metastases, patients may be enrolled if liver function test is =< five times the upper normal institutional limits

Patient must have signed informed consent

Patients must be willing to take the dexamethasone, folic acid and vitamin B12 supplementation as indicated in the protocol to reduce adverse drug toxicity

Patients must be willing to interrupt aspirin and other nonsteroidal anti-inflammatory drugs (NSAID) intake for 2 days before, day of, and 2 days after each chemotherapy treatment; low dose 80 mg aspirin and cyclooxygenase-2 (Cox-2) inhibitors are excluded from this restriction; if concomitant administration of an NSAID is necessary, patients should be monitored closely

Patients must have a life expectancy of greater than 12 weeks

Patients may not have concurrent or previous invasive malignancies, with the exception of non-melanoma skin cancer or no evidence of recurrence of previous malignancy within the last 5 years

Patients must have a current exam, blood work and any clinically indicated imaging studies within 4 weeks prior to study enrollment

Baseline folate and homocysteine blood levels

The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta

The ability to take folic acid, vitamin B12, and dexamethasone according to protocol

Patients who have received an investigational drug within the last 30 days that has not received regulatory approval

Presence of third space fluid which cannot be controlled by drainage; for patients who develop or have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before or during initiation of Alimta therapy, consideration should be given to draining the effusion prior to dosing; however, if, in the investigator's opinion, the effusion represents progression of disease, the patient should be discontinued from study therapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001910

Locations

United States, New York

Albert Einstein College of Medicine

Bronx, New York, United States, 10461

Columbia University Medical Center

New York, New York, United States, 10032

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10065

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Dennis Kuo

Albert Einstein College of Medicine of Yeshiva University

More Information

Responsible Party:

Dennis Yi-Shin Kuo, Principal Investigator, Albert Einstein College of Medicine of Yeshiva University